Westat Celebrates FDA Approval of First Freeze-Dried Plasma Product Licensed in the U.S.

Westat is proud to recognize a significant milestone in transfusion medicine with the U.S. Food and Drug Administration’s licensing of Ezplaz® Freeze-Dried Plasma—the first freeze-dried plasma product approved for use in the U.S. Ezplaz is intended for transfusion in adult patients who require plasma when other plasma products are not available.

Westat played a central role in the clinical research that supported the development of this groundbreaking product. The work was initially led by the late Melissa King, former Westat Vice President for Clinical Research, whose vision, expertise, and unwavering commitment established Westat as a trusted partner on the project.

“The FDA approval of Ezplaz marks the culmination of years of scientific collaboration, perseverance, and dedication,” said Sunitha Mathew, Westat’s Chief Growth Officer and former Practice Director for Clinical Research. “We are proud of the role Westat played in advancing this important product and grateful to Melissa for the vision and leadership that continue to inspire our work today.”

The Ezplaz Freeze-Dried Plasma program is preparing for a phase 4 postmarketing study. Westat assisted in developing the phase 4 study protocol and will provide clinical operations, data management, and statistical support for the conduct of the study.